
Diagnostic Systems
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EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 is an FDA 510(k)-cleared medical device (K862403) manufactured by Diagnostic Systems. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 10, 1986. Regulation: 8.